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Ortho serves the global clinical laboratory and immunohematology communities by providing products and services to hospitals, hospital networks, blood banks, and labs across more than 120 countries. The company brings sophisticated testing technologies, automation, information management, and interpretation tools to clinical laboratories around the world. The SARS-CoV-2 antibody test was developed at Ortho’s Global Center of Excellence for R&D in Rochester, New York.

The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack detects antibodies (including IgG and IgM) to SARS-CoV-2 that can be used to detect immune response to the virus. The test can be used in epidemiological research to help better understand the spread of the disease and can also be used to aid in the diagnosis of suspected COVID-19 patients in conjunction with molecular tests.

The test will run on Ortho’s flagship analyzer, the VITROS XT 7600 Integrated System, the VITROS 3600 Immunodiagnostic System, the VITROS 5600 Integrated System and VITROS ECi/ECiQ Immunodiagnostic Systems and can process approximately 150 tests in an hour. The systems are designed to remove barriers and adaptable for non-traditional laboratory environments as they do not require an external water supply to run.

“The unprecedented nature of this rapidly spreading virus required an immediate response from the diagnostics industry, and Ortho followed through on its commitment to help develop better ways to treat patients and provide robust data to help manage COVID-19,” said Chris Smith, chief executive officer. “At Ortho Clinical Diagnostics, the patient is at the heart of everything we do—because we believe behind every test is a life.”

“Given the incredible demand for information to change the tide of this pandemic, Ortho felt it was necessary to market as quickly as possible with a notification to the FDA,” added Smith. “We are working to make our antibody test kit available to the areas with the greatest need first and will be working in parallel to both increase our test kit production and follow additional regulatory pathways to secure further approvals.”